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机构地区:[1]浙江省金华职业技术学院化工与制药学院,浙江金华321007
出 处:《今日药学》2008年第4期30-31,71,共3页Pharmacy Today
摘 要:目的建立脉舒胶囊中木犀草素的含量测定方法并确定其限度。方法以木犀草素为对照品,以ODS-C18柱为分析柱,以甲醇-0.4%磷酸溶液为流动相,紫外检测波长为350nm的反相高效液相色谱法测定木犀草素含量。结果木犀草素进样量在0.033~1.04μg范围内线性良好,r=0.9998;平均加样回收率为100.5%,RSD为1.2%;每粒脉舒胶囊的木犀草素含量在4.37~4.93mg之间。结论本研究提出的含量测定方法准确稳定、简便易行,经方法学验证符合要求。木犀草素含量限度确定为不得少于4.0mg每粒胶囊。Objective To establish the assay method and determine the limit of luteolin in Maishu capsules. Methods The luteolin content was determined by RP-HPLC method. The best mensuration was on ODS-C18 column with MeOH-0.4% phosphatic acid (50:50) as a mobile phase, luteolin as the reference substance and detecting at 350 nm. Results The luteolin had a good linear relationship within the range of 0.033-1.04 μg (r=0.9998). The mean recovery of luteolin was 100.52%, the relative standard deviation (RSD) was 1.23%, and the luteolin contents varied from 4.37-4.93 mg per Maishu capsule. Conclusion The assay methods established in this study was accurate, stable, and convenient, complying with the requirements validated by methodology. The assay limit of luteolin was set as 4.0 mg per capsule.
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